+46(0) 70 58 60 200 info@medqtech.com Follow us

Medical Device
Regulatory
Compliance Experts
And Quality
Management System
Specialists

Your experienced partner that is passionate about the medical device industry

 
 

Comply
Effectively
with


MDR 2017/745


IVDR 2017/746


ISO
13485


ISO
14971


QSR
(FDA)


CE-marking process

Effectively ensure regulatory compliance and exceed quality goals throughout your organisation enabling innovation to drive forwards

 

MedQtech is an experienced team of medical device regulatory and quality compliance specialists.
We partner with medical device companies to ensure a streamlined journey to compliance and to drive quality enhancement throughout an organisation - ensuring compliance and quality systems are not barriers but enablers. We offer a portfolio of services that we tailor to our customers needs:

Medical Device Experts

Providing our customers with a regulatory and quality service mix designed for the medical device industry

 

Medical Device
Regulatory Compliance

 

Our services include:

  • CE marking process
  • Regulatory applications and registrations (EU/US)
  • Classification of medical devices
  • Gap analysis
  • Regulatory strategy
  • Act as your Person Responsible for Regulatory Compliance (PRRC)
  • Project management

And other regulatory affairs support

Regulatory Compliance Services Medical Device Regulatory Consultants

Medical Device
Quality Management

 

Our services include:

  • Quality management system implementation
  • ISO13485 certification readiness
  • QSR (FDA) compliance
  • Facilitation of ISO14971 Risk management
  • Act as your Quality and Regulatory resource
  • Develop/maintain QMS processes
  • Project management

And other quality management support

Quality Management Services Medical Device Regulatory Consultants

Partner with MedQtech to achieve your
medical device goals effectively and efficiently

 

Effectively extend your team with experienced medical device regulatory compliance and quality management system specialists - accelerate your speed to market access.

Medical Device Regulatory Consultants

Medical device focused

Medical Device Regulatory Consultants

Quality/regulatory/audit/ risk management service

Medical Device Regulatory Consultants

International compliance expertise (inc. EU & USA)

Medical Device Regulatory Consultants

Focused on project delivery

Medical Device Regulatory Consultants

Integrated eQMS

Medical Device Regulatory Consultants

Full project management capability

Medical Device Regulatory Consultants

Multi-eQMS skilled & enabled

Medical Device Regulatory Consultants

Commercial goal aware

 
 
Request A Consultative Led Video Meeting

MedQdoc Quality Management System (eQMS)

 

An eQMS solution designed and validated for the medical device industry:

 
  • Over 130 ready-to-use templates
  • Simple step-by-step workflow
  • Designed by compliance experts
  • Cloud based flexibility
  • Accelerate your medical device compliance while enhancing your quality management system.
 

MedQdoc allows you to get your consultancy services and QMS system from the same provider.

“MedQtech have constructively guided us through both the quality and regulatory compliance processes. Their experience has ensured that compliance and quality are positive contributions and not distractions to our business. The result is that we accelerated our compliance journey and enhanced our business processes for the future”

 

Medical device company

Our Valued Clients